MedTrace Logo

Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults

NCT05726344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-12-27

No results posted yet for this study

Summary

Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. There are differences among them regarding adherence, tolerance and adverse effects. Lactulose (LAC) is widely used in treating constipation. However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales. Adherence to bowel preparation significantly affects the result in the endoscopic study.

Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation). However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients.

Bowel cleansing preparation with PEG is widely used in clinical practice. Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.

Conditions

  • Lactulose
  • Polyethylene Glycol
  • Bowel Preparation
  • Colonoscopy
  • Bisacodyl

Interventions

DRUG

Lactulose

4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water

DRUG

Polyethylene Glycol 3350

4 tablets of Bisacodyl (5 mg) + 3 bottles Polyethylene Glycol 3350 (Polyethylene glycol 3350 60 g; sodium chloride 1.46 g; potassium chloride 745 mg; Sodium bicarbonate 1.68 g; anhydrous sodium sulfate 5.68 g; pineapple flavoring 483 mg) + 3 L of water

Sponsors & Collaborators

  • Hospital de Clínicas Dr. Manuel Quintela

    lead OTHER

Principal Investigators

  • IGNACIO MORATORIO, MD · HOSPITAL DE CLINICAS

  • MARIA B RUSSO, MD · HOSPITAL DE CLINICAS

  • FLORENCIA RODRIGUEZ, MD · HOSPITAL DE CLINICAS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2023-12-13
Completion
2023-12-13

Countries

  • Uruguay

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726344 on ClinicalTrials.gov